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Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study.

Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study. - Revised dosing recommendations of ciprofloxacin

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52449
Enrollment
58
Registered
2020-03-09
Start date
2020-08-19
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial infections inflammation

Interventions

1) Treatment with the revised reduced doses of ciprofloxacin for adult patients with impaired renal function receiving study medication at AMC or OLVG location Oost and recieving standard of care at

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - being treated with ciprofloxacin intravenously (iv) or orally (po) as part of standard care - age >= 18 years - being admitted to general wards of the Amsterdam UMC - location AMC, the OLVG- location Oost or Noordwest Ziekenhuisgroep location Alkmaar - informed consent is obtained

Exclusion criteria

Exclusion criteria: - receiving renal replacement therapy (i.e. haemodialysis, peritoneal dialysis, continuous venovenous hemofiltration or another way of renal replacement therapy), during the first 48 hours of treatment with ciprofloxacin - patients with cystic fibrosis (CF) - informed consent is not obtained

Design outcomes

Primary

MeasureTime frame
Drug exposure in the first 24 hours of treatment (AUC0-24)

Secondary

MeasureTime frame
1) Drug exposure after 24-48 hours of treatment (AUC24-48) 2) Attainment of relevant PK-PD targets: · AUC / MIC >= 125 · peak concentration (Cmax) / MIC >= 8 3) Adverse effects or toxicity-related problems possibly attributed to treatment with ciprofloxacin

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)